Covering the whole development process for the global biotechnology industry

Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.

Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.

Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.

Many technologies are used to characterize biological products, manufacturing processes, and raw materials. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion.

Even as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment.

A new product development approach will be described for the affinity capture of Mab’s from cell culture materials employing a novel base stable rProtein A ligand. Using a stable cellulose base bead with excellent flow properties coupled with a novel immobilization methodology, a next generation rProtein A capture resin has been developed with a high level of antibody binding capacity. The new Cellufine™ rProtein A resin shows C20% dynamic binding capacity (DBC) of >50 mg/ mL with polyclonal antibodies at…

Cellulose is well-known as a natural raw material that has mechanical strength, lower nonspecific adsorption, and good biocompatibility. Additionally, cellulose particles have unique pore-size characteristics appropriate for the chromatography of biopharmaceuticals. Mixed-mode chromatography resins are well known to have unique selectivity differences from traditional IEX or HIC resins. Cellufine™ MAX IB, a novel cellulose-based mixed-mode resin, has polyallyl amine partially modified with butyl groups ligand (Figure 1). The resin is used in flow-through mode after a protein A step in…

Cellulose is well known as a natural raw material that has mechanical strength, lower nonspecific adsorption, and good biocompatibility. In addition, cellulose particles have unique pore-size characteristics appropriate for chromatography of biopharmaceuticals. Ion-exchange chromatography (IEX) is an important step for biopharmaceutical manufacturing. Specifically, cation-exchange chromatography (CEX) can be used as a capture step in monoclonal antibody (MAb) purification. Recently, advanced IEX resins have been developed using polymer modification techniques. Initial screening of conditions such as pH and ionic strength is…

An efficient process for purifying virus particles is important when developing a vaccine. Cellufine Sulfate affinity chromatography medium has been used for manufacturing viral vaccines such as influenza virus, rabies virus, and Japanese encephalitis virus. Here we describe how to purify egg-derived influenza with Cellufine Sulfate media. Figure 1 shows a typical chromatogram of inactivated influenza virus A strain (H7N7) from allantoic fluid with Cellufine Sulfate media. Table 1 shows that adsorbed virus particles are eluted from the medium easily…